The role of the Australian Register of Therapeutic Goods
In the last few years the retail industry has moved increasingly into the online space, providing convenient access to goods. The health industry is no exception, with health professionals such as Dentists and General Practitioners looking to the internet when buying medical devices. However, it’s important to ensure that any medical devices you buy for use on patients are listed on the Australian Register of Therapeutic Goods. If they aren’t listed, you risk fines, registration infringements, claims of medical negligence and insurance policies not responding to claims. Australian Register of Therapeutic Goods listing is also an important consideration if you start buying medical devices from a new supplier who may not be aware of Australia’s laws.
What is the ARTG?
The Australian Register of Therapeutic Goods (ARTG) is the central point of control for the legal supply of medical devices in or from Australia. The Therapeutic Goods Act 1989 (Cth) defines a “medical device” very broadly to include a device used on humans with therapeutic benefits, which either has a physical or mechanical effect on the body or is used to measure or monitor body functions. Therefore, medical devices range from tongue depressors and syringes to MRIs and prosthetic joints.
Medical Devices used by health professionals should be:
- supplied by an Australian supplier who can confirm that the device is included on the ARTG; or
- manufactured or imported by a sponsor who has provided all the required manufacturing and safety information required to have the device listed on the ARTG before it is supplied or used.
Can I import a medical device for use in my clinical practice?
Yes, but you will then become a “sponsor” yourself and must comply with the therapeutic goods regulation, including:
- applying to the TGA to have each kind of medical device included on the ARTG;
- ensuring the device continues to meet all legislative requirements once they are on the market;
- ongoing record keeping;
- reporting any adverse events or problems; and
- taking preventative action, such as recalls, if necessary.
This is the case whether you purchase the device from overseas through the internet or from mail order catalogues, or at international conferences or trade exhibits.
What happens if I use a device that isn’t listed on the ARTG?
Sponsors and health professionals who use medical devices which aren’t listed on the ARTG could face penalties of up to five years imprisonment and/or 5000 penalty units (currently $850,000). In addition, it is possible that your professional registration may be impacted, you may have to respond to investigations by the Office of the Health Ombudsman and Australian Health Practitioner Regulation Authority, and your insurance may not cover an adverse event related to the non-listed device. What’s more, the device may cause serious harm to your patients and damage the trusted reputation you have built in your community.
Are there any exemptions?
There are some limited circumstances where unapproved products can be accessed legally, including the following:
- Authorised Prescriber Scheme which allows doctors with appropriate expertise to use unlisted items for a particular condition or class of patients in their direct care (see https://www.tga.gov.au/authorised-prescriber-scheme)
- Special Access Scheme which specifies some limited circumstances where practitioners may seek approval to use unlisted items, including for patients who are seriously ill and where currently listed items cannot be used to treat a particular patient (see https://www.tga.gov.au/form/special-access-scheme)
- Personal Importation Scheme which allows a person to import unlisted items for use only by them or their immediate family and not for resale (see https://www.tga.gov.au/personal-importation-scheme)
- Clinical trials for limited, approved experimental purposes (see https://www.tga.gov.au/clinical-trials)
How can I check if the device is listed?
Anyone can search the ARTG to confirm whether a device is already listed by visiting: https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg.
Additional general information on the regulation of Medical Devices is available here: https://www.tga.gov.au/medical-devices-overview.
Disclaimer: Any information provided in this article is general only and is not legal advice. If you require specific advice about the ARTG or any other legal issue, don’t hesitate to contact our specialist health business lawyers.